1428P - Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with l...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Small Cell Lung Cancer
Surgical Oncology
Therapy
Radiation Oncology
Presenter Yuki Misumi
Citation Annals of Oncology (2016) 27 (6): 493-496. 10.1093/annonc/mdw389
Authors Y. Misumi1, H. Okamoto1, K. Naoki2, Y. Hosomi3, T. Ogura4, N. Masuda5, K. Minato6, T. Yokoyama7, K. Kishi8, M. Nishikawa9, T. Kato10, N. Seki11, I. Goto12, K. Watanabe1
  • 1Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 240-8555 - Yokohama/JP
  • 2Department Of Respiratory Medicine, Keio University School of Medicine, Tokyo/JP
  • 3Department Of Thoracic Oncology And Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo/JP
  • 4Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama/JP
  • 5Respiratory Medicine, Kitasato University Hospital, Sagamihara/JP
  • 6Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 7Department Of Respiratory Medicine, Kyorin university Hospital, Mitaka/JP
  • 8Dept. Of Respiratory Medicine, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 9Department Of Respiratory Medicine, Fujisawa Municipal Hospital, Fujisawa/JP
  • 10Department Of Respiratory Medicine, Kanagawa Cancer Center, Yokohama/JP
  • 11Department Of Medical Oncology, Teikyo University, Tokyo/JP
  • 12Department Of Respiratory Medicine, Osaka Medical College, Takatsuki/JP

Abstract

Background

The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated.

Methods

Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objectives of the phase II study were efficacy, adverse events, and feasibility.

Results

Forty-one patients were enrolled (median age75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. The number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60).Toxicities were generally mild. There were 5 complete and 30 partial responses (response rate 90%).With a median follow-up of 80.4 months (n = 41), the median progression-free and overall survival times were 12.5 and 27.5 months, respectively.

Conclusions

Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.

Clinical trial identification

Legal entity responsible for the study

Thoracic Oncology Reserch Group (TORG)

Funding

Nippon Kayaku, Taiho, Lilly, Sanofi, Chugai, Astra Zeneca, Daiichi Sankyo, Shionogi

Disclosure

All authors have declared no conflicts of interest.